FDA, DOJ, and Industry to Present at ACI’s cGMPs Forum

NEW YORK - Nov. 25, 2013 - PRLog -- New York

Monday, Nov. 25, 2013

American Conference Institute (ACI) is pleased to announce that key representatives from the FDA, DOJ , Maryland U.S. Attorney’s Office, and industry will present at its inaugural Legal, Quality, Regulatory and Compliance Forum on current Good Manufacturing Practices which will take place in Washington, DC on January 23-24, 2014 (Workshops on January 22 and 24).

As Stephanie Butler, Division Manager of ACI’s  Life Sciences and Health Care  Division noted “this conference presents a unique opportunity to hear directly from every key government agency which is currently involved with cGMP enforcement and regulation.”  Butler went on to add that “FDA and DOJ enforcers have been adamant that they will remain steadfast and very aggressive in the pursuit and rectification of cGMP violations and as such this conference serves a vital need.”

Lisa J. Piccolo, Senior Industry Manager, Life Sciences and Health Care with ACI, stated “ACI is proud and honored to have the opportunity to have  Howard R. Sklamberg, Director, Office of Compliance, CDER, FDA;  Annamarie Kempic, Deputy Chief Counsel for Litigation, Office of Chief Counsel, FDA;  Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, USDOJ, and  Rod J. Rosenstein, U.S. Attorney for the District of Maryland present at this premier cGMP event.”  Piccolo further added that “in addition to the enforcers, leading in-house counsel and quality and compliance executives from major  biopharmaceutical companies will also present. As such, this program will serve the needs of biopharmaceutical company’s entire quality team – quality, legal, regulatory, and compliance.”


Co- Chairs:

• Raymond A. Bonner, Partner and Head, Food, Drug and Medical Device Compliance and Enforcement Practice, Sidley Austin LLP

• Mark J. Wanda, Deputy General Counsel-Regulatory, Astellas US LLC

FDA

• Howard R. Sklamberg, Director, Office of Compliance,  Center for Drug Evaluation and Research, United States Food and Drug Administration

• Annamarie Kempic, Deputy Chief Counsel for Litigation, Office of Chief Counsel,  United States Food and Drug Administration

DOJ

• Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, United States Department of Justice

US Attorney for the District of Maryland

• Rod J. Rosenstein, U.S. Attorney for the District of Maryland

Industry

• Jila Breeze, VP, Corporate Quality & Compliance, Apotex Inc.

• Damon Burrows, Vice President, Associate General Counsel, Allergan, Inc.

• Dr. Miles Davis, R.Ph, Ph.D, President and CEO, Sovereign Pharmaceuticals, LLC

• Sheila A. Denton, Executive Director and Division Counsel, Legal,  Boehringer Ingelheim, Ben Venue Laboratories

• Lori F. Hirsch, Managing Counsel,  Merck & Co., Inc.

• Elaine M. Laux, Vice President Quality Compliance and Audit, Sunovion Pharmaceuticals Inc.

• Stephen C. Mahoney, Senior Director, Global Quality and Compliance, Genetech

• Edwin Rivera-Martinez, Vice President, U.S. Quality Liaison, Global Quality, Sanofi

• Oscar Sanchez, Head of Quality America’s Region, Global Head of Strategy, Novartis

• Roger Schmitt, Vice President, Corporate Quality and Compliance, Forest Laboratories Inc.

• Carmen M. Shepard, Sr. Vice President, Global Policy and Regulatory Counsel, Mylan

• Frances M. Zipp, Group Executive, Vice President and Global Head of Quality, Teva

• Natasha Zuyev, Vice President Consent Decree, McNeil Consumer Healthcare

Law Firms

• Mark S. Brown, Partner, King & Spalding

• Douglas B. Farquhar, Attorney, Hyman Phelps & McNamara PC

• W. Warren Hamel, Partner and Chair, Investigations and White Collar Defense Practice, Venable LLP

• James R. Johnson, Attorney, Hogan Lovells US LLP

• Philip Katz, Partner, Hogan Lovells US LLP

• Gregory H. Levine, Partner, Ropes & Gray LLP

• Christina M. Markus, Partner, King & Spalding‚ LLP

• Gerald F. Masoudi, Partner, Covington and Burling LLP

• Stephen C. Payne, Partner, Gibson, Dunn & Crutcher LLP

• Nathan C. Sheers, Partner, Sidley Austin LLP

• Thomas J. Stukane , Senior Counsel, Johnson & Johnson

• Gary L. Yingling, Partner, Morgan Lewis & Bockius LLP

• Jennifer Zachary,  Partner,  Covington & Burling LLP

Consultants

• David L. Chesney, VP and Practice Lead, PAREXEL Consulting Strategic Compliance Services

• R. Owen Richards, President, Quantic Regulatory Services, LLC

• Dr. Roy J. Sturgeon, PhD, President, Lachman Consultant Services Inc.

View the full agenda and detailed information at: http://www.americanconference.com/cGMPs

About ACI -

A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world.

Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.

Headquartered in New York and led by Leigh Gilmore, Senior Vice President, has grown to produce more than 220 events each year, attended by thousands of senior delegates from across the country.